MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D ASSAY

Catalog Number	09038078160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na h3 other text : na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys vitamin d total iii on cobas e411 rack analyzer serial number (b)(6).The patient sample initially resulted in a vitamin d value of 19.36 ng/ml and this value was reported outside of the laboratory.The sample was repeated, resulting in a value of 29.45 ng/ml.The repeat value was deemed correct.
Additional Manufacturer Narrative
Calibration signals recovered within expectations and quality controls recovered within range.Upon review of the alarm trace, insufficient sample volume and clot pipetting errors were observed.These can indicate a potential sample quality issue.The field service engineer could not find any hardware issues.The probe alignments were adjusted.The liquid level detection voltage was checked and was within specifications.Performance testing passed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17100318
• Report Number: 1823260-2023-01929
• Device Sequence Number: 11245766
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 09038078160
• Device Lot Number: 66279701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown